Product Overview
【Drug Name】
Generic Name: Desloratadine Dispersible Tablets
Brand Name: Fubiding Desloratadine Dispersible Tablets 5mg*12 tablets
Pinyin Code: ZuoBiDing DiLvLeiTaDingFenSanPian 5mg*12Pian
【Main Ingredients】
Desloratadine.
【Appearance】
This product is a white or off-white tablet.
【Indications/Main Functions】
Used to relieve systemic and local symptoms of chronic idiopathic urticaria and perennial allergic rhinitis.
【Specifications】
5mg*12 tablets
【Dosage and Administration】
Oral administration. Place the tablet on the tongue with a small amount of water; it will disintegrate rapidly upon contact with saliva and be swallowed. For adolescents and adults over 12 years of age, take one tablet once daily. For children aged 2 to 12 years, take half a tablet once daily.
【Adverse Reactions】
The main adverse reactions of this product are nausea, dizziness, headache, drowsiness, dry mouth, and fatigue. Occasionally, somnolence, forgetfulness, and morning facial and peripheral edema may occur.
【Contraindications】
This product is contraindicated in patients with known hypersensitivity to the active ingredient or excipients.
【Precautions】
Because antihistamines can clear or reduce positive skin reactions to all allergens, this product should be discontinued 48 hours before any skin allergy test. Patients with liver damage, bladder neck obstruction, urethral tension, benign prostatic hyperplasia, or glaucoma should use this medication as directed by a physician.
【Drug Interactions】
No cardiovascular toxicity has been observed when desloratadine is used in combination with cytochrome P450 inhibitors ketoconazole and erythromycin. Concomitant use of desloratadine with other antisympathetic drugs or drugs with central nervous system sedative effects may enhance sleep. Food and grapefruit juice consumption do not affect the metabolism of desloratadine. Desloratadine does not enhance the impairing effects of alcohol on human performance when used concurrently with alcohol.
【Pediatric Use】
The efficacy and safety of desloratadine in children under 12 years of age have not been established.
【Use in Elderly Patients】
Not yet clear.
【Use in Pregnant and Lactating Women】
Administration of 34 times the recommended human clinical dose of desloratadine did not affect overall fertility in rats. No teratogenic or mutagenic effects of desloratadine were observed in animal studies. Because there are no clinical data on the use of desloratadine in pregnant women, the safety of its use during pregnancy has not been established. Desloratadine should not be used during pregnancy unless the potential benefits outweigh the possible risks. Desloratadine is excreted in breast milk; therefore, it is not recommended for breastfeeding women to take desloratadine.
【Overdosage】
In case of overdose, standard treatment measures should be considered to remove unabsorbed active substances. Symptomatic and supportive treatment is recommended. In a multi-dose clinical trial in adults and adolescents, subjects received up to 45 mg of desloratadine (9 times the clinically recommended dose) without any clinically relevant adverse reactions.
【Pharmacology and Toxicology】
Acute Toxicity: Death occurred in rats at an oral dose of up to 250 mg/kg (based on AUC, the exposure to desloratadine and its metabolites is approximately 120 times the clinically recommended daily oral dose). The oral LD50 in mice was 353 mg/kg (based on body surface area, desloratadine is approximately 290 times the clinically recommended dose). No death occurred in monkeys at an oral dose of up to 250 mg/kg (based on body surface area, desloratadine is approximately 810 times the clinically recommended dose).
【Pharmacokinetics】
Plasma concentrations of desloratadine can be measured 30 minutes after oral administration. Absorption is good, with peak plasma concentrations reached approximately 3 hours later. The elimination half-life is approximately 27 hours. The accumulation of desloratadine is consistent with its half-life (approximately 27 hours) and once-daily dosing interval. The bioavailability of desloratadine is dose-proportional within the range of 5 mg-20 mg.
【Storage】
Sealed.
【Packaging】
5 mg * 12 tablets/box.
【Shelf Life】
24 months
【Approval Number】
National Drug Approval Number H20040972
【Manufacturer】
Hainan Puli Pharmaceutical Co., Ltd.
